Takagi Seiko Co., Ltd.
NAKANO-SHI Nagano, JP
TAKAGI SEIKO CO., LTD. appears in FDA device records in NAKANO-SHI Nagano, JP. FDA records list 5 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 5 510(k) clearances for Takagi Seiko Co., Ltd. between 2007 and 2018. The busiest year on record is 2017, with 2. The most recent is 2018, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2007 | 1 |
| 2016 | 1 |
| 2017 | 2 |
| 2018 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K182491 | Applanation tonometer AT-2 | HKY | Substantially Equivalent | |
| K172728 | Applanation tonometer AT-1 | HKY | Substantially Equivalent | |
| K162636 | Marco Ultra M3, Marco Ultra M4 | HJO | Substantially Equivalent | |
| K152535 | Z5 Slit lamp microscope, Z2 Slit lamp microscope | HJO | Substantially Equivalent | |
| K063352 | ELLEX SLIT LAMP, MODEL 30XL | HJO | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 9710516 | 3001802794 | TAKAGI SEIKO CO., LTD. | 330-2 IWAFUNE, NAKANO-SHI Nagano 383-8585 JP | 2026 | and 2 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- HJOBiomicroscope, Slit-Lamp, Ac-Powered
- PUEBiomicroscope, Slit-Lamp, Ac-Powered, Exempt
- HMEChair, Ophthalmic, Ac-Powered
- HMDChair, Ophthalmic, Manual
- HPAFrame, Trial, Ophthalmic
- HRMMicroscope, Operating & Accessories, Ac-Powered, Ophthalmic
- HOOPerimeter, Ac-Powered
- HOSProjector, Ophthalmic
- HKNRefractor, Manual, Non-Powered, Including Phoropter
- HMFStand, Instrument, Ac-Powered, Ophthalmic
- HRJTable, Instrument, Powered, Ophthalmic
- HKYTonometer, Manual
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain